Post by Unicorn Medical

Spotlight Medical lands IVDR CE Mark for AI Breast Cancer Test Big news in the medical diagnostics field today! Spotlight Medical, the Paris-based oncology diagnostics company, has just received CE marking under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR) for their AI-enabled breast cancer test, myStage Dx. What does this mean? - Improved Risk Stratification: myStage Dx supports more precise, physician-led risk stratification in routine care for ER+/HER2− early breast cancer. - Better Decision Making: The AI test classifies patients into Low Risk or Not Low Risk categories, aiding physicians in making more informed treatment decisions. - Proven Efficacy: Clinical studies show that 95.4% of Low Risk patients remained free of distant recurrence and breast cancer-related death over nine years. This milestone paves the way for the widespread adoption of this innovative tool across Europe, integrating smoothly into existing oncology and pathology workflows. It's a win for the medical community and, most importantly, for patients who will benefit from personalised treatment plans. For hiring managers and candidates in the medical tech sector, this is a strong signal that innovation is rapidly reshaping diagnostics. The best teams are already planning ahead. #ai #BreastCancerTest #SpotlightMedical